vaccine therapy in treating patients with stage i, stage ii, or stage iii non-small cell lung cancer

Conditions: Lung Cancer

Summary: rationale: vaccines made from a person's white blood cells and allogeneic tumor cells may make the body build an effective immune response to kill tumor cells. purpose: this phase ii trial is studying how well vaccine therapy works in treating patients with stage i, stage ii, or stage iii non-small cell lung cancer.

objectives: * determine the immunologic effects of adjuvant vaccine therapy comprising autologous dendritic cells loaded with allogeneic non-small cell lung cancer (nsclc) cells in patients with unresectable stage iiia or iiib, or resected stage i-iiib nsclc. * determine the potential clinical efficacy of this vaccine in these patients. outline: this is an open-label study. patients are stratified according to type of prior primary therapy (surgical vs nonsurgical). patients undergo leukapheresis over 3-4 hours to harvest mononuclear cells for the production of dendritic cells (dc). dc are then pulsed with allogeneic non-small cell lung cancer cells to produce an autologous dendritic cell vaccine. patients receive vaccine intradermally once a month for 2 months in the absence of disease recurrence or unacceptable toxicity. patients are followed monthly for 4 months, every 6 months for 2 years, and then periodically thereafter. projected accrual: a total of 60 patients (30 per stratum) will be accrued for this study within 3 years.

Eligibility criteria:
disease characteristics: * histologically confirmed non-small cell lung cancer (nsclc) * meets 1 of the following stage criteria: * completely resected stage i-iiib disease * underwent surgical resection \> 4 weeks but ≤ 4 years ago * unresectable stage iiia or iiib disease and previously treated with definitive radiotherapy or chemotherapy \> 6 weeks ago * bronchoalveolar carcinomas allowed * clinically stable disease by chest x-ray or ct scan within the past 6 weeks * no progressive disease * no malignant pleural or pericardial effusions patient characteristics: age * 18 to 80 performance status * ecog 0-1 life expectancy * not specified hematopoietic * hemoglobin ≥ 9.0 g/dl hepatic * bilirubin ≤ 2.5 times upper limit of normal (uln) * ast and alt ≤ 2.5 times uln * no known history of infectious hepatitis renal * creatinine ≤ 3 mg/dl * ionized calcium ≥ 0.9 mmol/l (may be replaced) cardiovascular * no known new york heart association class iii-iv congestive heart failure * no hemodynamically significant valvular heart disease * no myocardial infarction within the past 6 months * no active angina pectoris * no uncontrolled ventricular arrhythmia * no stroke within the past year * no known cerebrovascular disease * no other significant cardiac disease by echocardiogram, stress test, or risk assessment by cardiologist (for patients suspected of cardiac disease by history or physical exam) immunologic * no known hiv positivity * no other immunosuppressive disorders, including chronic disorders other * not pregnant * negative pregnancy test * potassium ≥ 3.0 meq/l (may be replaced) * able to tolerate modest blood volume and electrolyte shifts during leukapheresis * no other malignancy prior concurrent therapy: biologic therapy * prior biologic therapy allowed * other concurrent biologic therapy allowed chemotherapy * see disease characteristics * no concurrent chemotherapy endocrine therapy * no concurrent steroids during and for 16 weeks after study treatment radiotherapy * see disease characteristics * no concurrent radiotherapy surgery * see disease characteristics other * prior neoadjuvant or adjuvant therapy for surgically resected patients allowed * no concurrent shorter courses of immunosuppressive medications during and for 16 weeks after study treatment * no concurrent chronic immunosuppressive medications * concurrent cyclooxygenase-2 inhibitors allowed

Keywords: stage i non-small cell lung cancer stage ii non-small cell lung cancer stage iiia non-small cell lung cancer stage iiib non-small cell lung cancer bronchoalveolar cell lung cancer